EMA has accepted GSK’s application to expand the Bexsero label with a single-dose booster for individuals aged 10 years and older vaccinated during infancy.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
GSK has announced that the European Medicines Agency has accepted its regulatory submission to expand the Bexsero® (Meningococcal Group B Vaccine) label to include a single-dose booster for individuals 10 years of age and older who were vaccinated against meningococcal group B disease during infancy. If approved, the proposed label expansion would simplify booster vaccination schedules and could help maintain immune protection during adolescence and young adulthood, periods associated with an increased risk of invasive meningococcal disease (IMD). In countries with established infant MenB immunization programmes, the proposed booster could also help reduce the overall burden of IMD.
About Bexsero®
Bexsero® is a recombinant multicomponent meningococcal group B vaccine indicated for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B. The vaccine is currently approved in Europe for individuals aged 2 months and older and is included in several national and regional immunization programmes. Globally, Bexsero is registered in 61 countries, with approximately 138 million doses distributed since 2015.
Regulatory Submission
The European Medicines Agency has accepted GSK’s regulatory submission to expand the Bexsero® label to include a single booster dose for individuals aged 10 years and older who completed the primary Bexsero vaccination series during infancy. The proposed label expansion is intended to reinforce immune responses during adolescence and early adulthood, a period associated with an increased risk of invasive meningococcal disease (IMD). Following validation and acceptance of the application, the submission has entered the EMA’s scientific review process and will be evaluated by the Committee for Medicinal Products for Human Use (CHMP) before a final decision by the European Commission.
Clinical Evidence Supporting the Submission
The submission is supported by a Phase 3b, open-label, multicentre study (NCT06995430) evaluating the immune response to a single Bexsero booster dose in individuals 10 to 20 years of age who completed the full primary vaccination series during infancy.
Key Findings
The Phase 3b study demonstrated that a single Bexsero booster dose effectively enhanced immune responses in individuals aged 10 to 20 years who had completed the primary vaccination series during infancy. These findings support the proposed use of a booster dose to reinforce immunity during adolescence in individuals previously vaccinated against meningococcal group B disease. GSK plans to present the full immunogenicity results and additional study data at the 25th International Pathogenic Neisseria Conference (IPNC) in September.
Clinical Significance
Invasive meningococcal disease (IMD) is a rare but rapidly progressing bacterial infection caused by Neisseria meningitidis. The disease can result in serious complications, including meningitis, septicemia, permanent neurological disability, limb loss, and death within hours if left untreated.
Although infants experience the highest incidence of IMD, adolescents and young adults represent a second peak in disease occurrence. This increased risk is partly attributed to behaviors that facilitate meningococcal transmission, such as close social contact through kissing, sharing drinks, and living in shared accommodation.
According to European surveillance data for 2024, serogroup B accounted for 56% of confirmed IMD cases among individuals younger than 65 years in the European Union and European Economic Area. The highest notification rate was reported in infants younger than one year (6.3 cases per 100,000 population), followed by children aged 1–4 years (1.38 per 100,000), while adolescents and young adults aged 15–24 years recorded the third-highest notification rate (0.83 per 100,000).
If approved, a single booster dose administered from 10 years of age onward could help sustain immune protection during this vulnerable period while simplifying booster vaccination schedules.
Regulatory Path
Following EMA validation and acceptance of the application, the submission will undergo scientific review by the Committee for Medicinal Products for Human Use (CHMP). If the CHMP issues a positive opinion and the European Commission grants approval, healthcare providers across the European Union could administer a single Bexsero booster dose to individuals aged 10 years and older who were vaccinated during infancy.
Future Impact
If approved, the proposed label expansion has the potential to simplify booster vaccination schedules for meningococcal B prevention in individuals previously vaccinated during infancy. The availability of a single-dose booster from 10 years of age onward could help reinforce immune responses during adolescence and young adulthood and facilitate booster implementation in countries with established infant MenB immunization programmes. If adopted, the updated recommendation could also contribute to broader public health efforts aimed at reducing the burden of invasive meningococcal disease across Europe.
Reference
About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.